Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents

Part of paid clinical trials in Aurora, Colorado.

Sponsor: University of Colorado, Denver
Study ID: NCT06575738
Phase: PHASE1
Status: Recruiting

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Conditions

Adolescent Obesity
Anti-obesity Agents
Bariatric Surgery
Body-Weight Trajectory
Obesity
Weight Loss Trajectory

Eligibility Criteria

Sex: ALL
Age: 12 Years - 24 Years
Healthy Volunteers: Not accepted

Interventions

Injectable semaglutide or injectable tirzepatide — DRUG
Subcutaneous weekly injectable medication
Standard postoperative care — BEHAVIORAL
Standard postoperative care consists of behaviorally-focused interventions delivered by the interdisciplinary Bariatric Surgery Center team targeting nutrition, physical activity, sleep, and mental health at standard postoperative intervals.

Study Details

The study plans to learn more about what happens to the body after bariatric surgery in people 12 to 24 years old. The study aims to understand why people respond differently to bariatric surgery and how to define success beyond weight loss alone. The study also plans to learn more about whether a medication (semaglutide or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 months after bariatric surgery, have not lost as much weight as expected.

Key Dates

First listed: Aug 28, 2024
Start date: Oct 11, 2024
Status verified: Jul 2026
Primary completion: Sep 1, 2027
Completion: Oct 1, 2027

Study Design

Enrollment: 40 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

No Intervention: Observational
Participants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 6 months postoperatively.
Experimental: Active Medication + Standard Postoperative Care
Participants can be enrolled between 6 and 24 months postoperatively and will receive usual interdisciplinary postoperative care plus weekly subcutaneous injectable semaglutide or tirzepatide for 26 weeks. Initial dose is 0.25mg (semaglutide) or 2.5mg (tirzepatide) and is escalated every 4 weeks as tolerated up to the max dose of 2.4mg for semaglutide or 15mg for tirzepatide for a total exposure of 26 weeks.
Active Comparator: Standard Postoperative Care
Participants can be enrolled between 6 to 24 months postoperatively and will receive usual interdisciplinary postoperative care.